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- Fulfill all applicable current Good Manufacturing Practices (cGMP) and Health Safety and Environment (HSE) regulations and relevant legislation by adhering to Hovione´s policies and procedures (COPs, HBR, SOPs and others) and industry standards while conducting all activities;
- Plan and design manufacturing processes that ensure the production of intermediates and final products according to the project plan (reliably, right first time, on time and within budget) and in compliance with cGMP, HSE regulations and internal policies and procedures;
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- Support and mentor production teams to optimize drug product manufacturing processes, minimize downtime, and maximize productivity;
- Identify and troubleshoot operational issues related to equipment and drug product processes, implementing innovative solutions to enhance efficiency and quality;
- Monitor and analyze production data to ensure compliance with regulatory standards and quality control measures;
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Join Hovione’s innovative team and play a key role in developing cutting-edge drug-device combination products. We are looking for a highly skilled Scientist to lead technical aspects of multiple projects, ensuring excellence from concept to manufacturing. This is an opportunity to work on challenging projects, drive innovation, and make a real impact in healthcare.
What You’ll Do
- Resolve a wide range of technical challenges across multiple projects to meet established targets.
- Execute projects according to agreed work plans, selecting optimal methods and techniques for best solutions.
- Provide technical support to projects beyond your direct responsibility.
- Present recommendations and contribute to idea...
Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
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Technical & Operational Leadership
- Lead the Precision Equipment Maintenance team, ensuring GMP‑compliant maintenance of laboratory and B22 drug‑product equipment.
- Apply strong technical expertise in preventive and corrective maintenance to ensure high reliability and optimal performance of critical systems.
- Support Quality Control and Manufacturing operations by minimizing downtime and improving equipment availability...
Performs procurement and sourcing functions which may include but are not limited to short and long-term category strategy development, supplier development and innovation enablement, commodity/services/goods procurement, outsourcing and vendor selection as well as project material sourcing/ planning/scheduling. Creates efficient integrated processes among internal functions and outside suppliers providing an efficient and transparent internal customer experience, compliant with quality assurance and sustainability requirements. Focuses resources on continuous improvement of the movement of materials through various processes and establishes key performance metrics and benchmarks to measure actual performance against goals on a regular basis. Promotes alignment by...
- Define and prioritize daily tasks to ensure timely and accurate sample analysis aligned with lab schedules and KPIs.
- To adhere to the laboratory testing schedule to achieve an efficient Quality Control (QC) system. Testing experience required using equipment HPLC, GC, and KF and using Empower software with the ability to troubleshoot in these techniques.
- Ability to perform review of data
- To maintain all checklists, laboratory records and notebooks...
Enables the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. Responsible for the definition, implementation and optimization of manufacturing processes and systems, aiming at full adherence to pre-established schedules while managing internal resources (people & equipment) and fulfilling costumer requirements.
- Fulfill and rigorously promote all applicable Good Manufacturing Practices (GMP) and Health Safety and...
Engages in the implementation of the Health, Safety and Environmental Management and Sustainability programs and procedures to safeguard employees and surrounding communities, developing requirements, supporting implementation through training and communication and monitoring implementation through audit and inspection. Conducts and supports incident investigations and risk assessments. Develops and maintains comprehensive knowledge and familiarity of regulatory and organization requirements and standards and works to ensure these requirements are fully implemented.
- Lead and develop the site supply chain team using servant leadership principles, promoting a culture of coaching, accountability, and alignment with corporate strategy and values.
- Ensure execution of all end-to-end supply chain activities (transportation, warehouse, import/export, distribution, planning) with a focus on long-term performance and...
As a CQV (Commissioning, Qualification, and Validation) Senior Engineer at Hovione, you lead complex engineering initiatives across pharmaceutical and chemical manufacturing environments. The role bridges technical excellence, regulatory compliance, and cross-functional collaboration to ensure robust, GMP-compliant systems and equipment.
Role Overview
You are specialized in the design, implementation, and qualification of manufacturing systems, utility infrastructures, and automation technologies. Your work ensures that...
Assures the maintenance of process analytical tools (PAT) methods and performance in the manufacturing assets in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Promotes the scientific excellence and innovation in the area of PAT and contributes with technical expertise to optimize PAT applications.
- Provide technical support (process analytical and statistical) in commercial projects;
Performs qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product. Recommends the analytical characterization package (Chemical, physical, performance) and controls the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Promotes the scientific excellence and innovation in the Analytical area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Develop and implement asset management strategies for critical equipment, including PMP, critical spare part identification, and optimization of spare part inventories. Ensure up-to-date and accurate equipment BOM;
- Lead troubleshooting efforts for equipment malfunctions; perform Root Cause Analysis (RCA) and implement effective Corrective and Preventive Actions (CAPA) to minimize downtime;
- Integrate and...
- Develop detailed civil engineering designs and plans for pharmaceutical facilities;
- Conduct site assessments and feasibility studies for new construction projects;
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Performs procurement and sourcing functions which may include but are not limited to short and long-term category strategy development, supplier development, commodity/services/goods procurement, outsourcing and vendor selection as well as project material sourcing/ planning. Focuses resources on continuous improvement of the movement of materials through various processes and establishes key performance metrics and benchmarks to measure actual performance against goals regularly.
- Lead cross-functional teams to deliver substantial...